MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT; CRICOTHYROTOMY KIT

Catalog Number 100/461/000

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received that a smiths medical tracheostomy tube was bent, making it difficult to secure the airway.

• Brand Name: MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KIT
• Type of Device: CRICOTHYROTOMY KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL, ASD INC.; boundary road; kent, hythe ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8140005
• MDR Text Key: 129583845
• Report Number: 3012307300-2018-08564
• Device Sequence Number: 1
• Product Code: OGP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/461/000
• Device Lot Number: 3053047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1